Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 1Bhavna Laboratories
03 1LGM Pharma
04 1Jai Radhe Sales
05 1HRV Global Life Sciences
06 1Medichem S.A
07 1USV Private Limited
08 1Apotex Pharmachem
09 1Aspire Lifesciences Pvt Ltd
10 1Biotechnica DWC
11 1Chongqing Huapont Pharmaceutical
12 2Curia
13 1Dalian Richon Chem
14 2Enaltec Labs Private Limited
15 2F.I.S. Fabbrica Italiana Sintetici
16 1FDC
17 1Glenmark Life Sciences
18 1Glenmark Pharmaceuticals
19 1Guangzhou Topwork Chemical
20 1Guangzhou Tosun Pharmaceutical
21 1Indoco Remedies Limited
22 1KOLON Life Science, Inc
23 1Kyowa Kirin
24 1Kyowa Pharma Chemical Co Ltd
25 1MSN Laboratories
26 1Medigraph Pharmaceuticals Pvt. Ltd.
27 1PHF SA
28 1Precise Group
29 2Sumitomo Chemical
30 1Sun Pharmaceutical Industries Limited
31 1Urquima S.A. Grupo Uriach
01 1Algeria
02 1Canada
03 4China
04 1France
05 15India
06 2Italy
07 4Japan
08 1South Korea
09 2Spain
10 1Switzerland
11 3U.S.A
01 13Active
02 4Inactive
03 18Blank
01 35Blank
01 1222MF10253
02 1222MF10280
03 1223MF10009
04 1224MF10094
05 1225MF10202
06 1226MF10140
07 1303MF10171
08 1304MF10045
09 1305MF10136
10 26Blank
01 1WC-0012
02 1WC-0021n
03 1WC-0055
04 1WC-0152
05 1WC-0159
06 1WC-0341
07 29Blank
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-07
Pay. Date : 2013-01-02
DMF Number : 23908
Submission : 2010-06-18
Status : Active
Type : II
NDC Package Code : 51014-7733
Start Marketing Date : 2010-04-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, BR, CA, CN |
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-23
Pay. Date : 2015-09-14
DMF Number : 22532
Submission : 2009-02-12
Status : Active
Type : II
NDC Package Code : 53296-0078
Start Marketing Date : 2010-05-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-04-29
Registration Number : 20210429-209-J-964
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460 Celra (GIRONA), Spain
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-28
Pay. Date : 2020-01-22
DMF Number : 24542
Submission : 2011-01-31
Status : Active
Type : II
Date of Issue : 2022-06-27
Valid Till : 2025-06-02
Written Confirmation Number : WC-0012
Address of the Firm :
NDC Package Code : 62147-0117
Start Marketing Date : 2009-12-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28389
Submission : 2014-06-16
Status : Active
Type : II
Registration Number : 226MF10140
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2014-07-31
Latest Date of Registration : --
NDC Package Code : 12079-2002
Start Marketing Date : 2013-10-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2021-05-20
Registration Number : 20210503-209-J-967(1)
Manufacturer Name : Kyowa Pharma Chemical Co., Ltd.
Manufacturer Address : 530 Chokeiji, Takaoka, Toyama 933-8511, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11801
Submission : 1996-01-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24408
Submission : 2010-12-17
Status : Inactive
Type : II
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